SimpleTrials CTMS/eTMF - 2026 Pricing, Features, Reviews & Alternatives

SimpleTrials CTMS and eTMF: Comprehensive, Affordable, and Scalable Clinical Trial Management

SimpleTrials is a cutting-edge cloud-based Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) platform designed to meet the needs of clinical trial sponsors, contract research organizations (CROs), and research sites. Our mission is to simplify and streamline clinical trial operations with an intuitive, affordable, and scalable solution. SimpleTrials combines advanced functionality, seamless integration, and transparent pricing to deliver the most comprehensive CTMS and eTMF solution for organizations of all sizes.

All-in-One CTMS Solution

SimpleTrials provides a robust suite of tools to support every phase of your clinical trial. Key features include:

Study Management: Centralize study setup, enrollment targets, and milestone tracking with configurable templates.

Site Management: Track site activation, essential documents, and communication logs.

Subject Tracking: Automate subject enrollment, visit schedules, and protocol compliance.

Financial Management: Build budgets, manage site payments, and forecast study costs with real-time reconciliation.

Key Risk Indicators (KRIs): Monitor study health through customizable KRIs and automated alerts.

EDC Integration: Bi-directional data flow between SimpleTrials and leading EDC systems for streamlined data consistency.

Integrated eTMF System

Our eTMF module ensures regulatory compliance and seamless document management. Key features include:

Document Upload & Version Control: Securely store and manage essential trial documents.

DIA TMF Reference Model Alignment: Pre-configured folder structure aligned with industry standards.

Electronic Signatures & Audit Trails: Maintain compliance with 21 CFR Part 11, GDPR, and HIPAA.

Real-Time Completeness Tracking: Visualize eTMF progress with interactive dashboards.

Role-Based Permissions: Control access to sensitive documents with detailed user permissions.

Affordable, Transparent Pricing

SimpleTrials is the first subscription-based CTMS and eTMF solution with transparent, predictable pricing. Our flexible subscription plans scale with your organization's needs — whether you're managing a single study or a global portfolio. No hidden fees, no long-term contracts — just straightforward pricing that fits your budget.

Seamless EDC Integration

SimpleTrials integrates with leading EDC systems to improve data consistency and operational efficiency. Bi-directional data flows eliminate redundant data entry, reduce errors, and accelerate decision-making.

User-Friendly Interface

Our intuitive platform requires minimal training, empowering teams to get up and running quickly. Role-based dashboards, guided workflows, and customizable templates simplify day-to-day clinical trial management.

Security & Compliance

SimpleTrials meets the highest standards of data security and regulatory compliance, including:

21 CFR Part 11 compliance

GDPR and HIPAA compliance

Data encryption

Comprehensive audit trails

Role-based access controls

Dedicated Customer Support

SimpleTrials is backed by an experienced customer success team providing personalized onboarding, training, and ongoing support. Our knowledge base, video tutorials, and live support ensure you're always set up for success.

Why Choose SimpleTrials?

Affordable, transparent subscription pricing

Comprehensive CTMS and eTMF capabilities

Seamless EDC integration

Real-time risk management and financial forecasting

Intuitive user interface

Dedicated customer support

Regulatory compliance with 21 CFR Part 11 and GDPR.

Discover how SimpleTrials can transform your clinical trial management with simplicity, affordability, and scalability.